TKUALA LUMPUR, Sept 7 — Novartis Malaysia reimagines medicines with the availability of brolucizumab, an anti-VEGF therapy by Novartis proven to slow the progression of wet age-related macular degeneration (AMD), or wet AMD for short.
Wet AMD is a leading cause of severe vision loss and blindness among people over the age of 65 in North America, Europe, Australia and Asia and impacts an estimated 20 million people worldwide.
An estimated 46,000 people Malaysians above 45 years of age today are known to suffer from the eye disorder and are at risk of irreversible blindness.
Wet AMD is a chronic condition where abnormal blood vessels grow underneath the macula. The macula is the central part of the retina in the eye that is responsible for sharp, clear, central vision and the ability to perceive colour.
As explained by Dr Nor Fariza Ngah, National Head of Ophthalmology Service from the Ministry of Health “These blood vessels are fragile and can leak, causing fluid and even blood to build-up in the macula, hence the term ‘wet’ AMD.”
“The leaking disrupts the normal macula architecture which ultimately damages and scars the macula, causing patients to experience a deterioration in their vision,” said Dr Nor Fariza.
Early symptoms of wet AMD include distorted vision (or metamorphopsia) and difficulties seeing objects clearly. Prompt diagnosis and intervention are essential.
As the disease progresses, cell damage increases, further reducing vision quality and may lead to a complete loss of central vision, leaving patients unable to read, drive or recognize faces and ultimately, lose their independence.
Decades ago, wet AMD patients had little hope of preserving their vision. As vision declined over time, blindness became an inevitability. Prior to the 1980s, no treatments were available.
Thermal laser was introduced during the early 1980s and in the early 2000s, photodynamic therapy became an option. However, it was not until 2005 that anti-vascular endothelial growth factor, or anti-VEGFs, were developed and offered patients the hope of improved vision.
“Anti-VEGF are drugs administered by injections that block the excess VEGF in the eye responsible for promoting the abnormal growth of blood vessels underneath the macula. This helps to ‘dry’ the fluid in the retina and slow the progression of wet AMD,” said Dr Nor Fariza.
Treatment typically begins with monthly injections and decisions to lengthen subsequent injection intervals are based on disease response to treatment. For the injection procedure, the patient lies down and after the eye is numbed, cleaned and draped, anti-VEGF injection is then administered intravitreally.
“These eye injections have helped patients maintain and, in many cases, even restore vision. However, wet AMD patients require frequent doses of anti-VEGF therapy to keep the disease process under control. Adhering to the injection schedule is important to ensure patients experience the intended therapeutic benefit and achieve optimal clinical outcomes. The frequent injections pose a challenge to patients with many struggling to keep up with their appointments,” she added.
In 2020, brolucizumab, the new anti-VEGF therapeutic agent by Novartis, received approval by the National Pharmaceutical Regulatory Agency in Malaysia8, as well as the first approval in the region.
The approval of brolucizumab was based on findings from the Phase III HAWK and HARRIER clinical trials, in which brolucizumab demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one (week 48).
Evidence of the effectiveness of brolucizumab can be seen in these results, based on global studies where the safety and efficacy of brolucizumab was compared with another anti-VEGF therapy already available on the market.
The brolucizumab molecule is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs2. By inhibiting VEGF, brolucizumab suppresses the growth of abnormal blood vessels and the potential for fluid leakage into the retina.
Additionally, brolucizumab also became the first FDA- approved anti-VEGF with the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after the loading phase with uncompromised efficacy.
In both clinical trials, approximately 30% of patients receiving brolucizumab gained at least 15 letters at year one. This was achieved with over half of patients maintained on the three-month dosing interval (56 per cent in HAWK and 51 per cent in HARRIER), while the remaining patients in the study were treated on a two-month dosing schedule.
Brolucizumab showed greater reduction in central subfield thickness (CST) as early as week 16, and by year one, fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF).
Retinal fluid is a key marker of disease activity6. Patients who were on brolucizumab experienced a greater reduction of fluid in the retina.
“Brolucizumab meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” said Patrik Grande, President and Managing Director of Novartis Malaysia.
According to Grande, the potential of three-monthly dosing intervals with brolucizumab may allow for less frequent injections. This can alleviate a burden for patients and their caregivers, improving compliance and overall outcomes.
“With a more tolerable treatment schedule, patients need not travel as much during this pandemic lockdown period and can have more time to focus on what’s important in their lives.”
“This is aligned with Novartis’ commitment of reimagining medicine and treatments for patients suffering from serious visual impairment and who live with this condition every day of their lives. In ophthalmology, our purpose is in developing and delivering life-changing medicines and therapies for diseases and conditions from front to back of the eye, enabled by data and transformative technologies,” added Grande.
Many people dismiss eye symptoms in the elderly, attributing it to “normal” vision loss due to old age or some other eye condition that may not require immediate attention. It is important to stress that reduced vision is not normal and should be evaluated by an eye specialist.
As Dr Nor Fariza remarked: “If you or your loved ones experience any symptoms that could indicate AMD, do not delay and consult an ophthalmologist immediately. Time is of the essence. Do not let your sight or the sight of your loved ones, go from blur to blind!”